Many individuals in health care facilities or those cared for at home are able to achieve sufficient caloric intake through eating standard diets and prepared meals. However, a sizable number of such patients are unable to ingest enough solid food to meet their body's nutritional needs. Examples of these individuals would include stroke or neurologically impaired patients, who have lost their ability to swallow effectively; critically ill, weak or comatose patients, who may be unable to chew sufficient quantities of food; patients suffering from obstructive lesions, such as cancer of the esophagus, who may be unable to swallow their food; and patients with head and neck trauma, such as fractured jaws and gunshot wounds who cannot chew solid food. For these patients, although caloric supplementation through parenteral, also known as intravenous feeding, it an option, enteral nutrition support is the more preferable method.
In response to this problem, liquid foods (medical nutritionals) have been developed for enteral feeding. The technique of enteral nutrition support initially utilizes a nasogastric tube to transport the liquid nutritional products from a container through the patient's oropharynx and thence into the stomach. However, there are well described complications associated with long term use of a nasogastric tube, and if after four to six weeks of use the inability to effectively swallow remains, patients should be switched to a gastrocutaneous feeding port. The gastrostomic feeding device or gastric portal, is placed into a gastrocutaneous stoma with the device typically featuring a relatively cylindrical component which extends through the stoma, and a tip portion which precludes easy withdrawal of the port from the stoma.
While it is possible to place the gastric port by means of a surgical procedure utilizing a general or local anesthetic, the preferred method for placement of these ports is percutaneous endoscopic gastrotomy (PEG) that involves use of an endoscope to visualize the insertion site on the gastric mucosa and the subsequent creation of an artificial opening into the stomach through the abdominal wall under local anesthesia.
Currently medical personnel can use one of three procedures in conjunction with the conducting of a percutaneous endoscopic gastrostomy. One procedure, known as Sacks-Vine, involves passing an endoscope down the throat until its terminus is in the interior of the stomach. A Seldinger needle is then externally inserted through the various tissue layers until it enters the stomach at a predetermined point. The needle is retracted leaving only the Seldinger cannula in place and a guidewire is then inserted through the stoma. The terminal end of the guidewire is grabbed by the endoscope and retracted up the throat. A tapered dilating catheter attached to the gastrostomy port is passed over the guidewire then inserted down the throat, through the esophagus and into the stomach so as to form, upon removal of the catheter through the abdominal skin, an opening wide enough to accommodate the trailing gastric port. At the proximal end of the gastrostomy port is a retention device that keeps the proximal end of the catheter from passing through the gastrocutaneous stoma. A feeding set adapter is then hooked up to the portion of the catheter external of the body that allows the gastrostomy port to be used for the actual feeding of the patient.
A second technique is known as Ponsky, wherein a suture or wire with a fixed loop is fed though a needle placed through the abdominal wall and into the stomach and the pulled up the esophagus and out the mouth. Suture or wire with a fixed loop is fixed to the distal end of a tapered dilating catheter that also has a suture or wire with a fixed loop attached to it. The tapered dilating catheter with an attached gastrostomy port is then is pulled down the throat, down the esophagus and into the stomach. Once again, the attached gastrostomy port used in this technique has a retention device at its proximal end. Once the catheter is in place, the adapter is connected and feeding commences in a manner similar to that of Sacks-Vine.
A third technique is known as the Russell technique, wherein a needle is placed through the anterior abdominal wall and into the stomach and a guidewire placed through it. The needle is removed leaving a gastrocutaneous guidewire. A series of dilators, similar to vessel dilators are passed one at a time over the guidewire, thereby enlarging the gastrocutaneous stoma from the outside of the patient. The last dilator may have on it a peel away sheath, which sheath accompanies the terminal end of that particular dilator into the interior of the stomach. Once the sheath is there, the dilator is removed and a balloon catheter is inserted into the peel-away sheath. The sheath is then retracted through the stoma and peeled away from the balloon catheter, which catheter is then filled such that the stomach is held adjacent to the abdominal wall by the interaction of the balloon catheter and a skin disk applied to the outside of the patient's body. A variation of this technique uses a last dilator that is larger than the balloon catheter to be placed, so that when the dilator is removed the gastrocutaneous stoma is large enough to accept the balloon catheter stiffened with a stylet.
Although all three methods permit the performance of a percutaneous endoscopic gastrostomy, the Sacks-Vine and Gauderer-Ponsky techniques, due to the introduction of the feeding tube retention device can cause the patient to experience both trauma and bleeding. Additionally, if there are any esophageal restrictions, the retention devices associated with the tubes utilized in these two techniques cannot pass through the restrictions or actually tear or lacerate the tissue around the restriction, coupled with the fact that extra medical attention may be required to retrieve the proximal end of the tube in the case of a problem.
Additionally, the first two techniques typically require another endoscopic procedure for removal of the tube upon cessation of enteral feeding or upon the necessity of changing the tube. This additional procedure results in additional trauma associated with any endoscopic procedure, as well as cost, to the patient. The Russell technique has as its primary disadvantage the fact that if the balloon fails prior to a mature stoma tract being formed, the stomach could fall away from the abdominal wall, leaving an open passage into the peritoneum. This open passage could result in peritonitis.
It is thus apparent that the need exists for an improved stoma creator and a method for using such a device for the primary placement of catheters for the administration of enteral nutrition, medications and other fluids into the stomach or small bowel.